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Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders

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ClinicalTrials.gov Identifier: NCT00267501
Recruitment Status : Recruiting
First Posted : December 21, 2005
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date December 15, 2005
First Posted Date December 21, 2005
Last Update Posted Date September 1, 2020
Study Start Date May 2005
Estimated Primary Completion Date January 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders
Official Title Eosinophils and Inflammation, an Expanded Study
Brief Summary The purpose of this study is to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic inflammation in humans.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with eosinophilic disorders and patients without eosinophilic disorders to serve as normal controls
Condition
  • Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory Disease
  • Food Allergy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2013)
5000
Original Enrollment
 (submitted: December 19, 2005)
500
Estimated Study Completion Date January 2050
Estimated Primary Completion Date January 2050   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older.
  • Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Kara Kliewer, PhD 513-636-4821 kara.kliewer@cchmc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00267501
Other Study ID Numbers 04-12-8
R01 DK075401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators Not Provided
Investigators
Principal Investigator: Marc E. Rothenberg, M.D., Ph.D. Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date August 2020